- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …working group and Steering Committee brand teams/extended brand teams, and product labeling committees. The Director has an established network of relationships ... input into convention planning/staffing, POA planning/staffing, sales training, product labeling committees and other department projects/initiatives This role has a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice ... and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions Provide strategic… more
- Genmab (Plainsboro, NJ)
- …programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, as required for the assigned projects Lead ... plans) and ensure that they are implemented, if applicable Collaborate with the Labeling Team Lead to develop Company Core Data Sheet and US Prescribing Information… more
- Genmab (Plainsboro, NJ)
- …a Clinical Drug Supply Manager, you will manage the packaging and labeling of clinical supplies, ensuring their efficient delivery for Genmab's global clinical ... QA and our CMOs to ensure timely packaging and labeling for clinical trials focused on treating cancer and...best possible outcomes for patients.The position reports to the Director of Global Clinical Drug Supply Operations based in… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution ... release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs,… more
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support… more
- Genmab (Plainsboro, NJ)
- …will join a highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the Global Clinical Drug Supply ... a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, Denmark.Main Responsibilities IncludeEngage with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for license renewals, responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in ... collaboration with the CDLContributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our ... pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation of… more
- J&J Family of Companies (Raritan, NJ)
- …will be considered as a single submission. We are currently seeking an Associate Director , Global Labeling Product Leader. This position can be located in ... Raritan, NJ; Titusville, NJ; or Horsham, PA. The Associate Director , Global Labeling Product Leader will be responsible for the following: + Lead the… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director , Global Labeling Strategist, plays a critical role in overseeing ... the development of labeling content (TPL, CCDS, USPI, and EU SmPC) and...this role ensures the delivery of effective and competitive labeling documents that drive differentiation and compliance in global… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Bausch Health (Bridgewater, NJ)
- …and coach Regulatory Ad/Promo staff under the direction of the Executive Director , Regulatory Advertising & Promotion. + Provides guidance and strategic support on ... may impact business. + Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert changes to assess and determine the impact… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title** : Senior Director , Global Regulatory Advertising and Promotion Therapeutic Area Head **Location:** Bridgewater, NJ / Cambridge, MA (must adhere to ... Office of Prescription Drug Promotion (OPDP) for drugs, Advertising & Promotional Labeling Branch (APLB) for biologics, and Division of Premarket and Labeling… more
- J&J Family of Companies (Raritan, NJ)
- …by the Company. **We are searching** **for the best talent for** **Associate Director , North America Regulatory Leader** **to** **be in Raritan, NJ.** **You will be ... strategy is in alignment with NA regional teams, CMC, labeling , commercial strategies, and the Target Product Profile. +...Product Profile. + Serve as a member of the Labeling Working Group, Clinical Teams, joint teams or joint… more
- Compass Group, North America (New York, NY)
- …but the start of a career where you can flourish. Job Summary The Director of Quality Assurance will lead the development and execution of comprehensive QA programs ... requirements. + Oversee the Allergen Preventive Controls Program, ensuring accurate allergen labeling and prevention of cross-contact in line with Kirkland & Ellis… more
- Ascendis Pharma (Princeton, NJ)
- Medical Director Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are ... the Endocrine Medical Sciences team for the US business, the Medical Director handles deliverables and activities associated with management and implementation of… more
- Merck (Rahway, NJ)
- **Job Description** **Role Summary** + The Associate Director , Global Scientific Content (AD, GSC), is a mid-level, headquarters-based role within Global Medical and ... Scientific Affairs (GMSA), and reports directly into the Director Team Lead, Therapeutic Area, GSC. + The AD,...and aligned with plans for publications, clinical trial development, labeling , and CORE, etc. and they meet the needs… more
- Bausch Health (Bridgewater, NJ)
- …company in discussions with OPDP. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of ... proposed labeling changes on product promotion. + Assures that promotional...drug promotion and working knowledge of Rx NDA and labeling development and approval process. + Demonstrated negotiation and… more
